Category C: Either studies
in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women
and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the
foetus.

Gen. MedInfo

IMPORTANT WARNING:

A small number of children, teenagers, and young adults (up to 24 years of
age) who took antidepressants ('mood elevators') such as imipramine during clinical studies became suicidal (thinking about harming or killing oneself or
planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely
to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about
how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18
years of age should not normally take imipramine except to prevent bedwetting, but in some cases, a doctor may decide that imipramine is the best medication
to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take imipramine or other
antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your
dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new
or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty
falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure
that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Your
healthcare provider will want to see you often while you are taking imipramine, especially at the beginning of your treatment. Be sure to keep all
appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication
Guide) when you begin treatment with imipramine. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can
obtain the Medication Guide from the FDA website:http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.

No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of
treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition.
You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or
anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited
mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your
doctor will decide what type of treatment is right for you.

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Why is this medication prescribed?

Imipramine
tablets and capsules are used to treat depression. Imipramine tablets are also used to prevent bedwetting in children. Imipramine is in a class of
medications called tricyclic antidepressants. It treats depression by increasing the amounts of certain natural substances in the brain that are needed to
maintain mental balance. There is not enough information to explain how imipramine prevents bedwetting.

How should this medicine be used?

Imipramine may come as a tablet and a
capsule to take by mouth. When imipramine tablets or capsules are used to treat depression, they are usually taken one or more times a day and may be taken
with or without food. When imipramine tablets are used to prevent bedwetting in children, they are usually taken one hour before bedtime. Children who wet
the bed early in the evening may be given one dose in the mid-afternoon and another dose at bedtime. Try to take imipramine at around the same time(s) every
day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take imipramine
exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose
of imipramine and gradually increase your dose.

It may take 1-3 weeks or longer for you to feel the full benefit of imipramine. Continue to take
imipramine even if you feel well. Do not stop taking imipramine without talking to your doctor. Your doctor will probably want to decrease your dose
gradually.

Other uses for this
medicine

Imipramine is also used occasionally to treat eating disorders and panic disorders. Talk to your doctor about the possible risks of
using this medication for your condition.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more
information.

What special precautions should I
follow?

Before taking imipramine,

tell your doctor if you are allergic to imipramine, any other medications, or any of the
ingredients in imipramine tablets or capsules. Ask your doctor or pharmacist for a list of the ingredients.

tell your doctor if you are taking a
monoamine oxidase (MAO) inhibitor such as isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, and tranylcypromine, or if you have stopped
taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take imipramine. If you stop taking imipramine, you should wait at
least 14 days before you start to take an MAO inhibitor.

tell your doctor what prescription and nonprescription medications, vitamins,
nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants (blood thinners) such as
warfarin; antihistamines; cimetidine; flecainide; levodopa (Sinemet); lithium; medication for high blood pressure, mental illness, nausea, seizures,
Parkinson's disease, asthma, colds, or allergies; methylphenidate; muscle relaxants; propafenone; quinidine; sedatives; selective serotonin reuptake
inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine, paroxetine, and sertraline; sleeping
pills; thyroid medications; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Your
doctor may tell you not to take imipramine if you have taken fluoxetine in the past 5 weeks.

tell your doctor if you have recently had a heart
attack. Your doctor may tell you not to take imipramine.

tell your doctor if you are being treated with electroshock therapy (procedure in which
small electric shocks are administered to the brain to treat certain mental illnesses), and if you have or have ever had glaucoma (an eye condition), an
enlarged prostate (a male reproductive gland), difficulty urinating, seizures, an overactive thyroid gland, or liver, kidney, or heart
disease.

tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking imipramine,
call your doctor.

if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking imipramine.

you
should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects
you.

remember that alcohol can add to the drowsiness caused by this medication.

tell your doctor if you use tobacco products.
Cigarette smoking may decrease the effectiveness of this medication.

plan to avoid unnecessary or prolonged exposure to sunlight and to wear
protective clothing, sunglasses, and sunscreen. Imipramine may make your skin sensitive to sunlight.

What special dietary instructions should I follow?

Unless your doctor tells
you otherwise, continue your normal diet.

What
should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the
missed dose and continue your regular dosing schedule.

What side effects can this medication cause?

Imipramine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go
away:

nausea

drowsiness

weakness or
tiredness

excitement or anxiety

nightmares

dry
mouth

skin more sensitive to sunlight than usual

changes in appetite or
weight

constipation

difficulty urinating

frequent
urination

blurred vision

changes in sex drive or ability

excessive sweating

Some side effects can be serious. If you experience any of the following symptoms or those listed
in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

jaw, neck, and back
muscle spasms

slow or difficult speech

shuffling walk

uncontrollable shaking
of a part of the body

fever, sore throat, or other signs of infection

difficulty breathing or
swallowing

severe rash

yellowing of the skin or eyes

irregular
heartbeat

Imipramine may cause other side effects. Tell you doctor if you have any unusual problems while you are taking this
medication.

What should I know about storage and
disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at
room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your
pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose,Â consult
your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this
medicine.

Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your
doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking,
as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you
are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Ref:Â Â U.S. National Library of Medicine.

This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a
registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it
take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or
liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or
otherwise.